FDA UDI
In Commercial Distribution
🇺🇸 United States
QuickTalker FT 12
DI: 00186648000807
·
Model: 10000037
·
Ablenet, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QuickTalker FT 12
- Primary DI
- 00186648000807
- Version / Model
- 10000037
- Catalog Number
- 10000037
- Company Name
- Ablenet, Inc.
- Labeler DUNS
- 791664543
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-21
- Public Version
- 1
- Public Version Date
- 2023-06-29
- Public Version Status
- New
- Public Device Record Key
- 5dcb7689-cd3e-436b-a46b-dc63e35b59bd
Device Description
The QuickTalker FeatherTouch 12 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 12 includes 48 unique messages available across five recording levels and provides an individual with robust communication options throughout the day.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65767 | Assistive speech generator | An electrically-powered device designed to facilitate communication by a patient with a disability and/or cognitive impairment by providing buttons with images that when pressed produce audible pre-recorded words or phrases associated with the images. It is a unit with a set of buttons/keyboard displaying symbols/pictures, a recording function, and a speaker. It is intended for use both in the home and healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00186648000807 | GS1 |